Accelerating the development of novel technologies and tools for the subcutaneous delivery of biotherapeutics.,Journal of Controlled Release

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Accelerating the development of novel technologies and tools for the subcutaneous delivery of biotherapeutics.
Journal of Controlled Release ( IF 10.5 ) Pub Date : 2020-02-24 , DOI: 10.1016/j.jconrel.2020.02.036
David S Collins ₁ , Manuel Sánchez-Félix ₂ , Advait V Badkar ₃ , Randall Mrsny ₄

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Subcutaneous (SC) delivery of biotherapeutics is well established as a route of administration across many therapeutic areas and has been shown to be effective and well-tolerated. It can offer several advantages over intravenous administration. This notwithstanding, there remain critical development issues and knowledge gaps in SC drug delivery. To articulate and address these issues, the SC Drug Delivery and Development Consortium was convened in 2018 as a pre-competitive collaboration of industry experts in drug delivery, device development, and commercialization. In this review, we outline the Consortium's vision and mission in advancing the development of patient-centered biotherapeutics and establishing a collaborative organization that facilitates open sharing of information and gives voice to diverse viewpoints from SC experts across industries and disciplines. Additionally, we describe the current landscape and challenges associated with SC administration of therapeutic proteins (specifically monoclonal antibodies) and offer insights into potential solutions to these challenges within the context of 8 problem statements developed by the Consortium to highlight key gaps, unmet needs, and actionable issues. Current and future opportunities to accelerate progress in the field through technological advances and the development of drug delivery tools are also discussed.

中文翻译：

加速开发用于皮下生物治疗的新技术和工具。

皮下（SC）递送生物治疗剂已被确立为跨多个治疗领域的给药途径，并且已被证明是有效且耐受性良好的。与静脉内给药相比，它可以提供几个优点。尽管如此，SC药物输送中仍然存在关键的发展问题和知识缺口。为了阐明和解决这些问题，SC药物输送和开发联合会于2018年召开，是药物输送，设备开发和商业化领域行业专家的竞争前合作。在这篇评论中，我们概述了联盟促进以患者为中心的生物治疗学发展并建立协作组织的愿景和使命，该组织促进信息的公开共享，并为跨行业和跨学科的SC专家提供不同观点的声音。此外，我们描述了与治疗性蛋白质（特别是单克隆抗体）的SC给药相关的当前形势和挑战，并在财团制定的8项问题陈述的背景下，针对这些挑战的潜在解决方案提供了见解，以强调关键差距，未满足的需求和可行的问题。还讨论了通过技术进步和药物输送工具的发展来加速该领域进展的当前和未来机会。我们描述了与治疗性蛋白质（特别是单克隆抗体）的SC给药相关的当前形势和挑战，并在财团制定的8个问题陈述的背景下提供了对这些挑战的潜在解决方案的见解，以强调关键差距，未满足的需求和可解决的问题。还讨论了通过技术进步和药物输送工具的发展来加速该领域进展的当前和未来机会。我们描述了与治疗性蛋白质（特别是单克隆抗体）的SC给药相关的当前形势和挑战，并在财团制定的8个问题陈述的背景下提供了对这些挑战的潜在解决方案的见解，以强调关键差距，未满足的需求和可解决的问题。还讨论了通过技术进步和药物输送工具的发展来加速该领域进展的当前和未来机会。

更新日期：2020-02-25

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